Endovascular graft having bifurcation and apparatus and method for deploying the same

ABSTRACT

Graft having a bifurcation for repairing an aneurysm in the vicinity of an aortic bifurcation in a patient comprising a main tubular body and first and second tubular legs joined to said main body in a bifurcation. The main body and the legs are formed of a flexible surgically implantable material. The main body and each of the first and second legs having an opening therein in communication with the other openings. Expandable spring attachments are secured to the main body adjacent the opening in the main body. An additional expandable spring attachment is secured to one of said legs adjacent the opening in said one leg.

[0001] This invention relates to an endovascular graft havingbifurcation and an apparatus and a method for deploying the same.

[0002] In Kornberg U.S. Pat. No. 4,617,932 there is disclosed abifurcated graft which has two legs with one leg being longer than theother leg. There is also disclosed a device and a method for insertingthe graft into an artery. However, there is a need for an improvedendovascular bifurcated graft and an apparatus and a method fordeploying the same.

[0003] In general, it is an object of the present invention to providean endovascular graft having bifurcation and an apparatus and a methodfor deploying the same which makes it possible to secure the graftfirmly in place traversing the aortic bifurcation with an apparatus andmethod which facilitates rapid deployment and placement of the same.

[0004] Another object of the invention is to provide a graft of theabove character which has a body portion that can be firmly fixed inplace in this aorta and has legs which can be firmly fixed in place inthe iliac arteries.

[0005] Another object of the invention is to provide an apparatus whichis relatively simple in construction and which greatly facilitatesplacement of the graft.

[0006] Another object of the invention is to provide a method of theabove character which is relatively simple and error free.

[0007] Additional objects and features of the invention will appear fromthe following description in which the preferred embodiments are setforth in detail in conjunction with the accompanying drawings.

[0008]FIG. 1 is a plan view of the apparatus for deploying anendovascular graft having a bifurcation of the present invention inwhich the graft is disposed within the capsule ready for deployment.

[0009]FIG. 2 is a cross-sectional view taken along the line 2-2 of FIG.1.

[0010]FIG. 3 is an enlarged cross-sectional view showing the slidingseal assembly utilized in the device shown in FIG. 1.

[0011]FIG. 4 is an enlarged perspective view of a graft having abifurcation incorporating the present invention.

[0012]FIG. 5 is an enlarged schematic view of the capsule showing themanner in which the graft having bifurcation is stored therein fordeployment.

[0013]FIG. 6 is an elevational view partially in cross section of aminor deployment device utilized as a part of the apparatus fordeploying the graft of the present invention.

[0014]FIG. 7 is an elevational view partially in cross section of theballoon dilatation catheter utilized in the minor deployment deviceshown in FIG. 6.

[0015]FIG. 8 is a perspective view of the hook assembly forming a partof the minor deployment device shown in FIG. 6 to be utilized with thegraft shown in FIG. 4.

[0016] FIGS. 9-19 are cartoons showing the method and apparatus utilizedin deploying the graft of the present invention.

[0017] In general the graft having a bifurcation for repairing ananeurysm in the aorta extending to or beyond the aortic bifurcation in apatient comprising a main tubular body and first and second tubular legsjoined to said main body in a bifurcation. The main body and the legsare formed of a flexible surgically implantable material. The main bodyand the first and second legs each have an opening therein incommunication with the other openings. Expandable spring attachmentmeans is secured to the main body adjacent the opening in the main body.Additional spring attachment means is secured to the first leg adjacentthe opening in that leg. The major deployment device comprises a capsulecatheter and a balloon catheter. The capsule catheter comprises aflexible elongate tubular member having proximal and distal extremities.A capsule is mounted on the distal extremity of the flexible elongatetubular member and has an open end. A graft is disposed within thecapsule. The balloon catheter comprises a flexible elongate tubularmember having proximal and distal extremities. A balloon is secured tothe distal extremity of the flexible elongate tubular member of theballoon catheter. The flexible elongate tubular member of the ballooncatheter extends through the graft and through the capsule in which thegraft is disposed and through the flexible elongated tubular member ofthe capsule catheter. Retention means is carried by the flexibleelongate tubular member of the balloon catheter and engages the graft. Acontrol mechanism is provided and has a handle portion adapted to begrasped by a human hand and has first and second parts movable relativeto each other. Means is provided for securing the flexible elongatetubular member of the capsule catheter to the first part. The flexibleelongate tubular member of the balloon catheter extends through thefirst part and through the control mechanism. Means is carried by thecontrol mechanism for causing movement of the first part with respect tothe second part to thereby cause the capsule to be withdrawn from overthe graft and permitting the retention means to retain the graft inposition so that it is ejected from the capsule as the first part ismoved relative to the second part.

[0018] The method for deploying a graft having bifurcation with a mainbody and first and second legs for deployment across the aorticbifurcation and into the first and second iliac arteries of a patient torepair an aneurysm therein comprising folding one of the legs of thegraft so it lies substantially parallel to the main body of the graft,introducing the graft through the femoral artery until the distalportion of the graft is disposed proximal of the aortic aneurysm,securing the proximal extremity of the graft with the other leg of thegraft being disposed in the first iliac artery, pulling down the foldedover leg into the second iliac artery securing the distal extremity ofthe first leg of the graft in the first iliac artery and thereaftersecuring the second leg of the graft in the second iliac artery.

[0019] The apparatus for deploying a graft 20 having a bifurcation ofthe present invention consists of a major deployment device 21 which isshown particularly in FIG. 1 and a minor deployment device 22 which isshown in FIG. 6. The major deployment device 21 incorporates a capsulecatheter 26 which is very similar to a capsule catheter disclosed inco-pending application Ser. No. 07/553,530 filed Jul. 13, 1990. Asdisclosed therein, the capsule catheter 26 is provided with a flexibleelongated tubular member 27 formed of a plastic which is loaded with aradiopaque material so that it will be visible under X-rays. An innerliner 28 of lubricous material is disposed within the tubular member 27.A flexible capsule 31 is secured to the distal extremity of the tubularmember 27. The capsule can have a length ranging from 10-40 centimetersand a diameter ranging from 6-9 millimeters.

[0020] A control mechanism 36 is secured to the proximal extremity ofthe tubular member 27. The control mechanism 36 is provided with amultipart housing 37, a portion of which serves as a handle adapted tobe engaged by the adult human hand. The housing 37 is formed in twoparts 37 a and 37 b of a suitable material such as plastic. The part 37a serves as a cylindrical pinion housing which has a longitudinallyextending bore 39 formed therein opening through one end thereof. Asmaller bore 41 is provided in the pinion housing 37 a and extendsaxially thereof and opens into the bore 39. The part 37 b is secured tothe part 37 a by suitable means such as ultrasonic bonding. The part 37b serves as a rack housing. A generally cylindrical rack member 42 isslideably mounted in the bore 39. Means is provided for causing relativemovement between the rack member 42 and the pinion housing 37 a andconsists of a rack and pinion assembly 43. The rack and pinion assembly43 consists of a rack 44 which is mounted in a flat 46 provided on therack member 42. The rack 44 is engaged by a pinion 47 mounted on a shaft48. The shaft 48 extends through the pinion housing 37 a and is providedwith an enlargement 48 a on one end. A knob 49 is mounted on the otherend of the shaft 48 and is provided for rotating the shaft 48 by fingersof one hand of the operator. The other hand of the operator holds thecontrol mechanism 36.

[0021] A detent assembly 51 is provided for permitting step-by-steprotation of the knob 49 in one direction but preventing rotation in anopposite direction. The detent assembly 51 consists of a plasticcylindrical housing 52 mounted in the wall of part 37 a and has aplunger 53 slideably mounted therein which is yieldably urged in adirection towards the knob 49 by a coil spring 54. The plunger 53 servesas a detent which is adapted to engage the circumferentially spacednotches 56 provided in the knob 49. The notches 56 are shaped so thatthe knob 49 can only be rotated in one direction and not in the otherdirection.

[0022] The distal extremity of the rack housing 37 b is provided with abore 61 (see FIG. 3) which opens through the distal extremity of thesame. A smaller bore 62 is provided within the rack member 42 andextends axially of the bore 61 and opens into the bore 61 and also opensthrough the proximal extremity of the rack member 42. A sliding sealhousing 63 is provided within the bore 61 and is secured therein bysuitable means such as an adhesive. The housing 63 is provided with abore 64 which opens through the proximal extremity of the housing 63 anda smaller bore 66 extending axially of the bore 64 and opening into thebore 64 and opening through the distal extremity of the housing 63. Thesliding seal housing 63 is provided with an annular recess 67 on itsdistal extremity which is adapted to receive the proximal extremity ofthe flexible elongate member 27 and is bonded thereto by suitable meanssuch as an adhesive.

[0023] The major deployment device 21 also includes a balloon catheterassembly 71 of the type described in co-pending application Ser. No.07/553,530 filed Jul. 13, 1990, and as disclosed therein consists of aflexible elongate tubular member in the form of a balloon catheter shaft72 having a single lumen therein and formed of a suitable material suchas irradiated polyethylene tubing. A separate balloon 74 is secured tothe distal extremity of the balloon catheter shaft 72 and is formed of asuitable material such as polyethylene. The balloon catheter shaft 72can have a suitable outside diameter such as 0.050″ and extend into ametal hypo tube 76 formed of a suitable material such as stainless steelhaving a suitable outside diameter, for example 0.062″. The metal tube76 extends into the inner liner 28 and extends into the bore 66 of thesliding seal housing 63 and into the bore 64 where it engages a pair ofthe spaced-apart cylindrical numbers 77 and 78 formed of a suitablematerial such as polycarbonate and a pair of spaced-apart siliconeO-rings 79 and 81, all of which are disposed within the bore 64 to formsliding seals. These sliding seals formed by the cylindrical members 77and 78 in conjunction with the O-rings 79 and 81 serve to prevent bodyfluids from coming into contact with operating parts of the controlmechanism 36 as for example, the rack pinion assembly 43. The stainlesssteel hypo tube 76 extends rearwardly towards the proximal extremitythrough the passage 62 of the rack member 42 and into the bore 41 of thepinion housing 37 a. A collet 82 is provided on the proximal extremityof the pinion housing 37 a. Means is provided for permitting freerotational movement of the hypo tube 76 in a fixed longitudinal positionand consists of a collet housing 83 having a threaded split cylindricalprotrusion 83 a with a collet cover 84 threaded thereon. The colletcover 84 has a hole 85 therein through which the hypo tube 76 passes.The collet housing 83 is rotatably mounted by an isolation ball bearingassembly 86 on a base 87 provided on the housing part 37 a. When thecollet cover 84 is rotated in one direction, the collet housingprotrusion 83 a is permitted to move to its normally open position topermit the collet 82 to open allowing the tube 76 to pass therethrough.When the collet cover 84 is rotated in an opposite direction it willclose the housing protrusion 83 a and lock the collet 82 onto the tube76. A Luer-type fitting 88 is mounted on the proximal extremity of thehypo tube 76.

[0024] A stabilization wire 89 of a suitable material such as stainlesssteel and of a suitable diameter as, for example, 0.018″ is disposedwithin the balloon catheter shaft 72 and extends the length thereof. Theproximal extremity 89 a of the pusher wire 89 is secured in a fixedposition to the luer fitting 88 in a suitable manner such as byembedding in the wall of the fitting 88 as shown in FIG. 1. The pusherwire 89 extends through the lumen of the balloon catheter shaft 72 intothe balloon 74 where it is fastened in a fixed position in the distalextremity of the balloon 74. A flexible, pre-shaped spring-like guidewire 91 is secured to the distal extremity of the balloon 74 by use of aplug 92 which also receives the distal extremity of the pusher wire 89.

[0025] Means is provided as a part of a control mechanism 36 forsupplying liquids for injection into the capsule 31 and consists of afitting 96 (see FIG. 3) which is mounted in the rack member 42 and whichis provided with a bore 97 in communication with the bore 66. A flexibletube 99 is connected to the fitting 96 and is provided with a Luer-typefitting 101 having a stop cock 102 therein. The rack housing or cover 37b is provided with a slot 103 through which the tube 99 extends and canmove longitudinally during rectilinear movement of the rack member 42.

[0026] A stabilization button 106 is mounted on the balloon cathetershaft 72 in a fixed position spaced a predetermined distance from theproximal extremity of the balloon 74 as for example, a distance of 5-10centimeters. A pair of spaced-apart radiopaque markers 107 in the formof platinum bands are provided on the balloon catheter shaft 72 withinthe balloon 74.

[0027] The endovascular graft 20 having a bifurcation is shown in FIG.4. The graft 20 has many characteristics which are similar to theexpandable intraluminal vascular graft disclosed in co-pendingapplication Ser. No. 07/553,530 filed Jul. 13, 1990. However, the graft20 differs significantly from the graft disclosed therein in that it isprovided with a bifurcation as hereinafter described. The graft 20 is anexpandable intraluminal vascular graft which is provided with a maindeformable cylindrical body 112 having an open end 113. The body 112 isprovided with a bifurcation or crotch 114 at the other end which opensinto first and second legs 116 and 117, having open ends 118 and 119generally opposite the open end 113. Continuous walls form the body 112and the legs 116 and 117 and are woven of surgically implantablematerial such as Dacron-type fiber. One material found to beparticularly satisfactory is a USCI DeBakey soft woven Dacron vascularprosthesis. The main body 112 can have a length ranging from 5 to 30centimeters with each of the legs having a length ranging from 2 to 15centimeters. The body 112 can have a maximum expandable diameter rangingfrom 12 to 30 millimeters whereas the legs 116 and 117 can have maximumdiameters ranging from 6 to 12 millimeters.

[0028] Radiopaque markers 121 are provided on the main body 112 and alsoon the legs 116 and 117 and can be formed of a suitable material such aslengths of platinum wire secured to the fabric of the graft by suitablemeans such as Dacron sutures.

[0029] Expandable spring attachment means 126 is secured to theexpandable main body adjacent the opening 113. Also expandable springattachment means 127 is secured to the first leg 116 adjacent theopening 118. These expandable spring attachment means 126 and 127 serveas anchoring means for securing the graft 20 to vessel wall in which thegraft 20 is disposed. The expandable spring attachment means 126 isconstructed in a manner similar to that described in copendingapplication Ser. No. 07/553,350 filed Jul. 13, 1990, and serves toyieldably urge the opening 113 in the main body 112 from an initialcompressed or collapsed position to a subsequent expanded position.Similarly, the expandable spring attachment means 127 serves toyieldably urge the open end 118 from an initial compressed or collapsedposition to a subsequent expanded position. As explained in saidco-pending application Ser. No. 07/553,350 filed Jul. 13, 1990, theexpandable spring attachment means 126 and 127 are formed of a pluralityof vees 131 with the apices 132 being formed with helical coil springs133 to yieldably urge the legs 134 and 136 of each of the vees 131outwardly in directions in the planes in which the vees lie. Asdisclosed in the co-pending application Ser. No. 07/553,350 filed Jul.13, 1990, the apices 133 lie in three longitudinally spaced-apartparallel planes extending transversely of the axis of the expandablespring attachment means in which the first plane is disposed internallyof the open end and the second plane lies in a position which isexternal of but in close proximity to the open end and the third planeis spaced a substantial distance beyond the open end.

[0030] Hook-like elements 141 are provided at the apices 132 which aredisposed beyond the open end 113 for the attachment means 126 and theopen end 118 for the attachment means 127. The hook-like elements 141are bonded to the legs 136 of the vees 131 by suitable means such aswelding. The hook-like elements 141 have hooks 142 which are of a lengthwhich is sufficient to penetrate into the vessel wall and slightlybeyond the vessel wall in which the graft is to be placed. Theexpandable spring attachment means 126 and 127 are secured to the graftby Dacron polyester suture material 144 as shown particularly in FIG. 4.

[0031] A pull line 146 is secured to the leg 117 in a region which isclosely approximate the end of the leg 117 at the opening 119. The pullline can be formed of a suitable material such as Nylon having adiameter from 0.005″-0.010″. The pull line 146 is continuous and extendsthrough small holes 147 provided in the material forming the graft 20.The pull line 146 which is doubled over onto itself and has adoubled-over length of approximately 40-60 centimeters with the ends ofthe pull line 146 being tied together in a knot 148. A lead tube 151with a lumen 152 is positioned over the pull line 146 so it is adjacentthe leg 117. The lead tube 151 is necked down at 153 by suitable meanssuch as by heat in a region distal of the knot 148 (see FIG. 4) so thatthe lead tube 151 is retained on the pull line 146. A cutout 154 isprovided in the lead tube 151 proximal of the knot 148.

[0032] The balloon catheter assembly 71 is disposed within the capsule31 in a manner also shown in FIG. 5 in which the balloon tube or shaft72 extends coaxially of the main body of the graft 112 coaxially of thefirst leg 116. The stabilization button 106 is preferably disposedwithin the graft in a position which is just proximal of the bifurcationor crotch 114. By positioning the pusher button 106 where shown in FIG.5, it is near to the major portion of the material forming the graft 20which is folded up within the capsule 31. This is desirable because themass of material provided in that region of the capsule facilitatespushing the graft 20 out of the capsule as hereinafter described.

[0033] The minor deployment device 22 as particularly shown in FIG. 6consists of a capsule catheter 161, a balloon catheter 162 and aseparate expandable spring attachment means 163. The separate ballooncatheter 162 is shown in greater detail in FIG. 7 and the separatespring attachment means 163 is shown in FIG. 8. The capsule catheter 161consists of a flexible tubular member 166 formed of a suitable materialsuch as polyethylene having an inside diameter ranging from 0.050 to0.080″ and an outside diameter ranging from 0.075 to 0.100″. The tubularmember 166 can have a suitable length as for example, 15-25 centimeters.The tubular member 166 has a lumen 167 extending the length thereof andhas proximal and distal extremities 168 and 169. A conventional TuohyBorst adapter 171 is mounted on the proximal extremity 168. A smallcapsule 172 formed of suitable material such as stainless steel ismounted on the distal extremity 169 of the tubular member 166. It can beof a suitable size, as for example a length of 10 to 30 millimeters andan inside diameter of 4 to 6 millimeters with a wall thickness rangingfrom 0.006 to 0.015″. The capsule 172 is provided with an open end 173through which the separate expandable spring attachment means 163 isadapted to be inserted.

[0034] The balloon catheter 162 as shown in FIG. 7 consists of aflexible elongated tubular member 176 formed of a suitable material suchas polyethylene and which serves as the balloon shaft and is providedwith an outside diameter ranging from 0.04 to 0.0060″ and an insidediameter ranging from 0.015 to 0.030″. An expandable balloon 177 isformed integral with the flexible elongate tubular member 176 near thedistal extremity thereof. The balloon 177 is formed of the samepolyethylene material as the tubular member 176 and can have a diameterranging from 6 to 12 millimeters and a length ranging from 1 to 2centimeters. A wye adapter 179 is mounted on the proximal extremity 181of the flexible elongated tubular member 176. A Tuohy Borst adapter 182is mounted on the main arm 183 of the wye adapter 179. A stop cock 184is mounted on the side arm 186 of the wye adapter 179.

[0035] An additional elongate flexible tubular member 188 of a suitablematerial such as polyethylene is provided and extends from the TuohyBorst adapter 182 through the lumen 189 provided in the tubular member176 and through the balloon 177 where the distal extremity of theelongate flexible tubular of the member 188 is bonded to the distalextremity of the tubular member 176 to provide an airtight seal for theballoon 177. The tubular member 188 is provided with a lumen 191extending the length thereof as adapted to receive a guide wire 196 of asuitable size as for example, one having a diameter of 0.018″ so thatthe guide wire 196 can extend through the tubular member 176 and throughthe balloon 177 and extend beyond the distal extremity of the tubularmember 176. The guide wire 196 is of a conventional type and is utilizedfor guiding the balloon catheter as hereinafter described. A pair ofspaced-apart radiopaque markers of a suitable material such as goldbands 198 are provided on the tubular member 188 within the balloon 177.

[0036] The coaxial annular space between the exterior of the tubularmember 188 and the interior of the tubular member 176 serves as anannular balloon inflation passage and is in communication with thesidearm 186 so that the inflation and deflation of the balloon can becontrolled by the stop cock 184.

[0037] The expandable spring attachment means 163 shown in FIG. 8 has aconstruction very similar to the expandable spring attachment means 126and 127 hereinbefore described. The expandable spring attachment means163 is provided with a plurality of vees 201 having apices 202 formed bycoil springs 203 which have legs 204 and 206 expandable and contractiblewithin the plane of the vee. The vees 201 are configured in such amanner so that the apices 202 lie in only two spaced-apart parallelplanes perpendicular to the longitudinal axis of the expandable springattachment means, rather than the three planes disclosed for expandablespring attachment means 126 and 127. Hook-like elements 207 are bondedto the legs or struts 204 or 206. The hook-like elements 207 areprovided with hooks 208 which face outwardly of the expandable springattachment means and in a direction towards the other end of the springattachment means. Additional hook-like elements 209 are provided on theother end of the spring attachment means 163 by bonding the same bysuitable means such as welding to the struts 204 and are provided withhooks 211 which face outwardly and extend in an opposite direction tothe hooks 208, toward the other end of the spring attachment means. Inthis way it can be seen that the hooks 208 and 211 face in oppositedirections, hooks 208 being angled slightly distally and hooks 211 beingangled slightly proximally, and serve to prevent distal and proximalmigration of the graft leg 117 to which the expandable attachment means163 is attached as hereinafter described.

[0038] The expandable spring attachment means 163 is adapted to becompressed and mounted within the capsule 172 as shown particularly inFIG. 6. Means is provided for pushing the expandable spring attachmentmeans 163 out of the open end 173 of the capsule 172 and consists of astabilization button 216 which is formed on the balloon shaft orflexible elongate tubular member 176. The pusher member 216 can beformed in a suitable manner such as by forming a ring of longitudinallycompressed polyethylene on the shaft 176.

[0039] Operation and use of the apparatus hereinbefore described forperforming the method of the present invention for deploying anendovascular graft having bifurcation may now be briefly described asfollows.

[0040] In conjunction with the cartoons which are set forth in FIGS.9-19, let it be assumed that it is desired to repair an aneurysm in theabdominal aorta 222 close to or involving the aortic bifurcation 221 andpossibly involving the left and right iliac arteries 223 and 224 in ahuman patient. In this example, the left iliac artery 223 is referred toas the first iliac artery, and the right iliac artery 224 is referred toas the second iliac artery. Graft legs 116 and 117 are identifiedsimilarly. Initially the patient is prepared with either general,regional, or local anesthesia. A cut-down is performed in the leftfemoral artery as indicated by the opening 226 in the first leg 223.Similarly, a cut-down or percutaneous access is performed in the rightfemoral artery as indicated by the opening 227 in the second leg 224. Aguide wire 231 of a conventional type, as for example a guide wirehaving a diameter of 0.038″, is introduced through the opening 226 inthe left femoral artery 223 and then is passed over the aorticbifurcation 221 and down through the right artery 224 and out throughthe opening 227 in the right femoral artery. This procedure isaccomplished in a conventional manner under fluoroscopy as shown in FIG.9.

[0041] Thereafter as shown in FIG. 10 the lead tube 151 which isextending out of the distal extremity of the capsule 31 is threaded overthe guide wire 231 extending out of the hole 226 in the first artery 223and thence into the left cut-down or hole 226 and over the guide wire231 in the left artery, over the guide wire 231 in the aorticbifurcation 221 and then down the second artery 224 through the rightcut-down 227 so that the distal extremity of the lead tube 151 extendsfor a substantial distance out of the cut-down 227. During the time thatthe lead tube 151 is being advanced, the distal extremity of the guidewire 231 is caused to pass through the cut-out 154 so that the distalextremity of the guide wire 231 is accessible and can be held steadywhile the lead tube 151 is advanced over it.

[0042] Thereafter, the guide wire 231 can be pulled out by grasping theproximal extremity of the guide wire 231 the cut-out 154 in the leadtube 151 and pulling out the guide wire 231 while holding the distalextremity of the lead tube 151 so as to prevent the lead tube 151 frombeing pulled back into the cut-down 227. The distal extremity of thelead tube 151 is then clamped with a hemostat 236 as shown in FIG. 11 tobe sure that the lead tube 151 is not pulled back into the cut-down 227during future steps in the method of the present invention. The majordeployment device 21 is then introduced into the left cut-down 226 byfirst passing the balloon guide wire 91 and then the balloon 74 throughthe left cut-down 226 followed by the capsule 31, which is advanced tothe position shown in FIG. 11 by pushing on the tubular member 27.During the advancement, the operator may need to place gentle tractionon the lead tube 151 to facilitate advancement of the capsule 31 towardthe aortic bifurcation 221. When the capsule 31 reaches the aorticbifurcation 221, it is necessary for the operator holding the lead tube151 to permit more of the lead tube 151 to enter the cut-down 227 topermit further advancement of the capsule 31 up the aorta so that thedistal spring attachment means 126 of the graft 20 within the capsule 31can be positioned in a region which is 1-2 centimeters proximal of theproximal extremity of the aneurysm to be corrected by the graft 20 beingdeployed. As shown in FIG. 12 the distal extremity of the capsule 31 isdeployed well beyond the aortic bifurcation 221. As soon as thephysician has determined that the capsule 31 is in the proper position,the physician uses one hand to hold the control mechanism 36 while atthe same time using the fingers of the other hand to rotate the knob 49and the pinion 47 to retract the rack member 42. This causes retractionof the tubular member 27 and the capsule 31 mounted thereon while thehypo tube 76 is retained in a stationary position by the collet 82 thatis retained by the collet housing 83. As the capsule 31 is withdrawn,the stabilization button 106 carried by the tubular member 72 inengagement with the graft 20 as shown particularly in FIG. 5 causes thegraft 20 to be gradually ejected from the capsule 31 as the capsule 31is withdrawn. Upon continued retraction of the capsule 31, the proximalexpandable spring attachment means 126 will clear the capsule 31 andwill spring outwardly to cause the hooks 142 carried thereby to comeinto engagement with the aortic vessel wall proximal to the aneurysm tobe repaired as shown in FIG. 12.

[0043] The physician, using one hand to hold the control mechanism 36,uses his other hand to release the collet 82 in order to unlock the tube76 by rotating the collet cover 84 relative to the control mechanism 36.The physician repositions the hand not holding the control mechanism 36so as to grasp the portion of the metal hypo tube 76 extendingproximally of the control mechanism 36. The hypo tube 76 is then pulledrearwardly or proximally. The balloon 74 is thereby drawn into theproximal extremity of the main body portion 112 of the graft 20 as shownin FIG. 13 so that the intermediate portion of the balloon 74 is ingeneral registration with the expandable spring attachment means 126.The balloon 74 is then inflated by supplying gas to the ballooninflation lumen by attachment of a syringe or other suitable inflationmeans to the Luer fitting 88. Upon inflation of the balloon 74 the hooks142 carried by the proximal expandable spring attachment means 126 arefirmly seated circumferencially in the normal aortic wall proximal tothe aortic aneurysm. With the balloon 74 still inflated and firmlyholding the proximal attachment means 126 against the aortic wall, thecapsule 31 is then further retracted by holding tube 76 in fixedposition release to the patient with one hand and retracting the handle36 with the other hand in order to expose the entire length of thesecond leg 117 as shown in FIG. 13. The capsule 31 is still furtherretracted to clear most of the first leg 116 as shown in FIG. 14. Asthis is being accomplished, the second leg 117 of the graft 20 is pulleddown into the artery 224 by pulling on the lead tube 151 so that theentire length of the leg 117 of the graft 20 is disposed in the arterialvessel 224 and extends substantially below the bifurcation 221 and belowthe aneurysm which is to be repaired. Further retraction of the capsule31 is accomplished by holding tube 76 fixed with one hand and retractingthe handle 36 with the other hand until the distal expandable springattachment means 127 carried by the first leg 116 clears the capsule 31and springs into engagement with the wall of the arterial vessel 223. Itshould be appreciated that during the foregoing procedures, the balloon74 remains inflated in the attachment means 126 to prevent anyaccidental dislodgement of the Attachment means 126 during the removalof the capsule 31 and during the placement of the second leg 117 of thegraft 20 into the artery 224 by pulling on the lead line 151.

[0044] The balloon 74 is then deflated so that it is in a collapsedposition and the balloon is withdrawn from the attachment means 126 intothe first leg 117 until its intermediate portion is in registration withthe attachment means 127. The balloon 74 is then reinflated to expandthe hooks 142 of the attachment means 127 into firm engagement with thearterial wall of the vessel 223 as shown in FIG. 15.

[0045] After this has been accomplished, the balloon 74 is againdeflated and is advanced up through the main body of the graft 112 andagain into the attachment means 126. The balloon 74 is then reinflatedas shown in FIG. 16 and serves to hold the graft 20 in place while theprocedures for securing the distal extremity of the second leg 117 areaccomplished. It is likely in many instances that this step of againsecuring the proximal extremity of the graft by inflating the balloon inthe attachment means 126 may be unnecessary. However to ensure that thegraft 20 will not move after it has been deployed, as additionalinsurance, the balloon 74 can be positioned in the attachment means 126and reinflated.

[0046] The minor deployment device 22 is next utilized. The guide wire196 forming a part thereof is introduced through the cutdown 227 intothe second artery 224 so that it extends into the second leg 117 of thegraft 20 and beyond the bifurcation. The balloon catheter 162 isthreaded onto or advanced over the guide wire 196. The balloon catheter162 is disposed within the capsule catheter 161. The minor deploymentdevice 22, with its balloon catheter 162 and capsule catheter 161, isadvanced into the cutdown 227 while applying gentle traction to the leadtube 151 to keep the second leg 117 of the graft 20 taut. The balloon177 and the capsule 172 are thus introduced into the second leg 117. Thecapsule 172 is positioned so that when the expandable spring attachmentmeans 163 contained therein is deployed therefrom, the spring attachmentmeans 163 will be at the distal extremity of the second leg 117 of thegraft 20 as shown in FIG. 16. The expandable spring attachment means 163is then forced out of the capsule 172 by the physician using one hand tograsp the wye adapter 179 and hold it in a fixed position relative tothe patient and using the other hand to grasp the Tuohy Borst adapter171 and gradually withdraw the same to retract the capsule 172 from overthe expandable spring attachment means 163 which is held in the desiredposition by the stabilization button 216 carried by the tubular member176. As soon as the expandable spring attachment means 163 clears thecapsule 172 it will spring out with one row of hooks 208 moving intoengagement with the distal extremity of the second leg 117 and with theother row of hooks 211 moving into engagement with the wall of thearterial vessel 224. Alternatively the capsule 172 is positioned so thatwhen the expandable spring attachment means 163 contained therein isdisplaced therefrom, the expandable spring attachment means 163 isdisposed within the second leg 117 so that both rows of hooks 208 and211 move into engagement with the distal extremity of the leg 117 andengage the wall of the vessel 224.

[0047] In order to firmly implant the hooks 208 and 211 of theexpandable spring attachment means 163, the balloon 177 in its deflatedcondition is brought down into the attachment means 163 so that itsintermediate portion is disposed within the attachment means 163. Thisis accomplished by pulling on the wye adapter 179 which applies apulling force to the tubular member 176 to pull the balloon 177 towardsthe distal extremity of the leg 117 of the graft 20 while at the sametime withdrawing, if so desired, the capsule catheter 161 by pulling onthe adapter 171 which applies a pulling force to the tubular member 166.As soon as the balloon 177 is in the proper position, the balloon 177 isinflated by suitable inflation means as, for example, a syringe attachedto the stop cock fitting 184 and inflating the balloon 177 to thedesired pressure to force the hooks 208 and 211 firmly into the distalextremity of the leg 117 of the graft 20 and the arterial vessel 224.

[0048] After the inflation of the balloon 177 has been accomplished, theballoon 177 can be deflated by removing the syringe opening the stopcock 184. The balloon catheter 162 and the capsule catheter 161 then canbe removed through the cutdown 227 so that all that remains is the leadtube 151 extending through the cutdown 227. The lead tube 151 is cutdistal to the knot 148 in the vicinity of the necked down section 153and the lead tube 151 is pulled off of the pull line 146. One end of theNylon pull line 146 is then grasped to pull out the Nylon pull line 146by having the free end travel up into the cutdown 227 and pass throughthe distal extremity of the leg 117 of the graft 20. It is then removedin its entirety through the cutdown 227. The right cutdown 227 is thenrepaired. Following that, the balloon 74 is deflated. The hypo tube 76is retracted relative to the control mechanism 36 to move the ballooninto engagement with the capsule 31. The collet 82 is then locked ontothe hypo tube 76 by turning the knob 84 relative to the controlmechanism 36. The control mechanism 36 is then withdrawn to remove thecapsule catheter 27, the balloon catheter shaft 72, and the balloon 74through the cutdown 226. The left cutdown 226 is then repaired. Thiscompletes the steps for deployment of the graft 20 across an aorticbifurcation to repair an aneurysm. The patient can then be brought outof general anesthesia if employed.

[0049] It should be appreciated that the graft having bifurcation canhave legs of various lengths depending upon the type of aneurysm whichis to be repaired. For example, one leg can be longer than the other.The legs can both be short in cases in which the aneurysm has a shortdistal aortic neck and does not include the iliac arteries. They wouldbe longer in aneurysms which involve the iliac arteries as well. It isgenerally desirable that the graft extend at least one centimeter beyondthe most distal portion of the most distal aneurysm in the vessels.

[0050] From the foregoing it can be seen that there has been provided agraft having a bifurcation in which the main body of the graft as wellas the legs are firmly attached in the arterial vessels so that theyaccidentally cannot become dislodged from the location in which they arefixed in the arterial walls. The method which is utilized for deployingthe graft with legs is relatively simple and can be accomplished withina relatively short period of time. The major and minor deploymentdevices which are utilized in the procedure are constructed in such amanner that they are easy to utilize with a minimum of training. The useof a folded-over second leg of the graft in the capsule makes itunnecessary to move the main body of the graft as high in the aorta aswould be otherwise necessary in order to permit the second leg of thegraft to clear the aortic bifurcation

thereby permit the second leg to be placed in the second iliac artery.Thus, the risk incurred by moving the graft and its capsule and anyassociated debris past the renal arteries located well above the aorticbifurcation is greatly reduced thereby reducing the chance of occludingthe renal arteries and causing embolization to the renal arteries.

1. A graft having a bifurcation for repairing an aortic aneurysm closeto or involving the aortic bifurcation in a patient comprising a maintubular body and first and second tubular legs joined to said main bodyin a bifurcation, said main body and said legs being formed of aflexible surgically implantable material, said main body and said firstand second legs each having an opening therein in communication with theother openings, expandable anchor means secured to the main bodyadjacent the opening in the main body and additional expandable anchormeans secured to one of said legs adjacent the opening in said one leg.2. A graft as in claim 1 wherein said expandable anchor means and saidadditional expandable anchor means are in the forming spring attachmentmeans, each having hook-like elements disposed outwardly therefromadapted to come into engagement with the arterial wall of the patient.3. A graft as in claim 1 together with a lead line removably connectedto the other of said legs.
 4. A graft as in claim 3 wherein said leadline includes a single line which is looped through said materialforming said other leg and a knot formed in said pull line remote fromsaid leg.
 5. A graft as in claim 4 together with the flexible tubularmember extending over said pull line into a region in close proximity tothe other leg, means carried by said tubular member engaging said knotto prevent said tubular member from accidentally being removed from saidpull line, said flexible tubular member having cutout therein.
 6. In amajor deployment device, a capsule catheter and a balloon catheter, saidcapsule catheter comprising a flexible elongate tubular member havingproximal and distal extremities, a flexible capsule mounted on thedistal extremity of the flexible elongate tubular member, said capsulehaving an open end, a graft disposed within the capsule, said ballooncatheter comprising a flexible elongate tubular member having proximaland distal extremities, balloon secured to the distal extremity of theflexible elongated tubular member of the balloon catheter, said flexibleelongated tubular member of the balloon catheter extending through thegraft and through the capsule in which the graft is disposed and throughthe flexible elongated tubular member secured to the capsule, retentionmeans carried by the flexible elongated tubular member of the ballooncatheter and engaging the graft, a control mechanism having a handleadapted to be grasped by a human hand and having first and second partsmovable relative to each other, means for securing the flexible elongatetubular member of the capsule catheter to the first part, said flexibleelongate tubular member of the balloon catheter extending through saidfirst part and through said control mechanism and means carried by thecontrol mechanism for causing movement of the first part with respect tothe second part to thereby permit the capsule to be withdrawn from overthe graft and permitting the retention means to retain the graft in aposition so that it is ejected from the capsule as the first part ismoved relative to the second part.
 7. A device as in claim 6 whereinsaid graft has expandable anchor means capable of moving outwardly assoon as the expandable anchor means clears the capsule.
 8. A device asin claim 6 wherein said means for causing relative movement between thefirst and second parts includes a rack and pinion.
 9. A device as inclaim 6 wherein said control mechanism includes means for preventinglongitudinal movement of the flexible elongate tubular member of theballoon catheter relative to the control mechanism.
 10. A device as inclaim 9 wherein said control mechanism includes means for operating onsaid means for preventing longitudinal movement of the flexible elongatetubular member of the balloon catheter to permit longitudinal movementof the flexible elongate tubular member of the balloon catheter relativeto the control mechanism.
 11. A device as in claim 6 wherein said graftis in the form of a main body and first and second legs adjoining themain body and extending away from the main body to provide abifurcation, one of said legs being folded over and lying generallyparallel to the main body when the graft is disposed within the capsule.12. A device as in claim 11 together with a lead tube connected to thefolded-over leg and extending out of said capsule.
 13. A device as inclaim 12 together with a single pull line secured to said leg andextending through said leg and having its free ends knotted together,said lead tube extending over the pull line into the vicinity of saidcapsule and means formed in the tube engaging the knot to prevent thelead tube from being pulled off of the pull line.
 14. A device as inclaim 13 wherein said lead tube is provided with a cutout proximal ofthe knot.
 15. In a minor deployment device, a capsule catheter and aballoon catheter, said capsule catheter comprising a flexible elongatedtubular element having proximal and distal extremities, a capsulesecured to the distal extremity, a fitting provided on the proximalextremity, the balloon catheter comprising a flexible elongate tubularelement having proximal and distal extremities, a balloon carried by thedistal extremity, the balloon being disposed distally of the capsule andhaving the flexible elongate tubular member of the balloon catheterextending through the capsule and through the flexible elongate tubularmember of the capsule catheter and a fitting mounted on the proximalextremity of the flexible elongate tubular member of the ballooncatheter for inflating and deflating the balloon, said flexible elongatetubular member of the catheter having retention means provided thereonand disposed within the capsule, and an expandable spring attachmentmeans disposed within the capsule and being in engagement with theretention means.
 16. A minor deployment device as in claim 15 togetherwith a guide wire extending through the balloon catheter.
 17. In amethod for deploying a graft having bifurcation with a main body andfirst and second legs for deployment across an aortic bifurcation of apatient to repair an aneurysm close to or involving the aorticbifurcation and the associated first and second iliac arteries, foldingthe second leg of the graft so it lies substantially parallel to themain body of the graft to provide a folded-over second leg, introducingthe graft with the folded-over second leg through the first iliac arteryuntil the graft is disposed proximal of the bifurcation, securing theproximal extremity of the graft with the first leg of the graft beingdisposed in the first iliac artery, pulling down the folded-over secondleg into the second iliac artery, securing the distal extremity of thefirst leg in the first iliac artery and thereafter securing the secondleg of the graft in the second iliac artery.
 18. A method as in claim 17wherein said folded-over leg is provided with a lead tube, the steps ofusing the lead tube to pull the folded-over second leg into the secondiliac artery.
 19. A method as in claim 18 wherein the graft is providedwith an opening in the main body and an opening in each of the legstogether with expandable spring attachment means secured to the graft inthe vicinity of the opening in the main body and additional expandablespring attachment means secured to the first leg of the graft adjacentthe opening of the leg, together with a capsule catheter having aflexible elongate tubular member with proximal and distal extremitiesand with a capsule mounted on the distal extremity and having an openend, together with a balloon catheter having an inflatable balloon, anda deployment device with a supplemental expandable spring attachmentdisposed therein, said graft being disposed in said capsule so that thefirst named and additional expandable spring attachment means aredisposed within the capsule, the steps of introducing the capsule intothe arterial vessel of the patient so that the distal extremity of thecapsule is disposed proximal to the aortic bifurcation and proximal ofthe proximal extremity of the aneurysm, withdrawing the capsule whileretaining the graft therein stationary to cause the expandable springattachment means in the vicinity of the opening in the main body to beejected from the capsule to permit the expandable spring attachmentmeans to expand, retracting the balloon catheter so that the balloon isdisposed in the first named expandable spring attachment means,inflating the balloon to urge the first named expandable springattachment means into engagement with the wall of the aorta, furtherwithdrawing the capsule so that the folded over second leg clears thecapsule, pulling down the folded-over second leg into the second iliacartery, still further withdrawing the capsule until the additionalspring attachment means carried by the first leg of the graft clears thecapsule and is permitted to expand, deflating the balloon of the ballooncatheter, bringing the deflated balloon into the additional expandablespring attachment means, expanding the balloon to urge the additionalexpandable spring attachment means into engagement with the wall of thefirst iliac artery, using a deployment device to introduce supplementalexpandable spring attachment means into the second iliac artery and intothe second leg of the graft, urging the supplemental expandable springattachment means out of the deployment device and permitting thesupplemental expandable spring attachment means to expand intoengagement with the graft and into the wall of the second iliac arteryand removing the capsule catheter and the balloon catheter.
 20. A methodas in claim 19 together with an additional balloon catheter, andincluding the steps of advancing the additional balloon catheter intothe supplemental expandable spring attachment means, expanding theballoon into engagement with the supplemental spring attachment means tourge the supplemental spring attachment means into engagement with thesecond leg of the graft and the wall of the second iliac artery,removing the additional balloon catheter and removing the lead tube.